SOFT TISSUE REPAIR BEST-IN-CLASS - Ortho RTi Presentation | November 2018 Brent Norton, CEO - Ortho Regenerative
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BEST-IN-CLASS SOFT TISSUE REPAIR Ortho RTi Presentation | November 2018 Brent Norton, CEO
FORWARD-LOOKING STATEMENTS
These materials contain forward-looking statements relating to the business of Ortho Regenerative Technologies Inc.
(the “Company” or “Ortho RTi”) including with respect to the progress, timing and completion of the Company’s research,
development, and clinical trials for product candidates, the Company’s ability to manufacture, market, commercialize,
partner and achieve market acceptance for product candidates, its ability to protect its intellectual property and operate
its business without infringing on the intellectual property rights of others, the Company’s estimates for future
performance and its estimates regarding anticipated operating losses, future revenues, capital requirements, and its
needs for additional financing, and any M&A timelines. In addition, even if the Company’s actual results or development
are consistent with the forward-looking statements contained in this presentation, those results or developments may not
be indicative of the Company’s results or developments in the future. In some cases, you can identify forward-looking
statements by words such as “could”, “should”, “may”, “expect”, “anticipates”, “believes”, “intends”, “estimates”, or similar
words. These forward-looking statements are based largely on the Company’s current expectations as of the date of this
presentation and are subject to a number of known and unknown risks and uncertainties and other factors that may
cause actual results, performance, or achievements to be materially different from any future results, performance or
achievements express or implied by these forward-looking statements. In particular, the Company’s expectations could
be affected by, among other things, uncertainties involved in the development and manufacture of medical devices,
unexpected results, unexpected regulatory actions or delays, competition in general, the Company’s ability to obtain or
maintain patent or other proprietary intellectual property protection. In light of these risks and uncertainties, there can be
no assurance that the forward-looking statements made during this presentation will, in fact, be realized, and no
representation or warranty is given as to the completeness or accuracy of the forward-looking statements contain in
these materials.
Ortho RTi is providing the information in these materials as of this date, and we disclaim any intention or obligation to
publicly update or revise any forward-looking statements, whether as a result of new information, future events, or
otherwise.
2
WHAT IF…
we could heal/repair soft tissue injuries such as
shoulder tears, knee meniscus, cartilage tears?
What would happen to one’s What would happen to What would happen to joint
pain and pain management? productivity and longevity? replacement surgery and medical
costs?
Lets fix the injury not the
complications of the injury
3
ORTHO RTi
SNAPSHOT
Ortho RTi is developing best-in-class medical products
to heal shoulder and knee injuries using its proprietary
technology
• Founded in 2015
• Technology developed by Dr. Michael Buschmann, PhD,
former Canada Research Chair in Cartilage Tissue
Engineering at Ecole Polytechnique, now Bioengineering
Chair at George Mason University
• Headcount: 19, including 13 scientists under contract
• Earlier product validated mode of action, clinical efficacy, and
safety at 5 years
• ~ $1 million non-dilutive Prima Grant for 2017-18, $12 million
in research funding to date
• Focused on developing technology for use in:
• Shoulder rotator cuff repair
• Knee meniscus and cartilage repair
• Other commonly injured joints – elbow, ankle, hip, etc.
4
SOFT TISSUE INJURIES
A LARGE UNMET NEED
4 million Americans with rotator cuff injuries
and are at risk for disability
• 25% of U.S. adults over the age of 40 develop a rotator
cuff tear, with aging ‘weekend warriors’ escalating the
problem
• Only 600,000 surgeries are performed, with 50% failing
within 6-12 months
• 50% of rotator cuff tears progress in size in 3 years
2 million meniscal injuries annually; 16% of all
orthopaedic surgeries
• 1.2 million meniscal surgeries annually with (partial)
removal the only option
• Increasing at an average of 8% per year as population
ages and remains active
1.7 million cartilage injuries detected annually;
125,000 treated
5
THE ORTHO PRODUCT
A proprietary biopolymer (Sticky Scaffold)
mixed with patient blood (Bioactive) in the OR
• Freeze-dried in a standard vial Ortho injected
at repair site
• Fits seamlessly into current surgical procedures
• Takes about 5 minutes
• No additional equipment needed
Advantages
ü Biologically repairs tissue
ü One-time, inexpensive procedure
ü Low cost of goods (90%+ margins)
ü Simple to manufacture
ü Long shelf life at room temperature Rotator Cuff
6
ORTHO’S BIOPOLYMER
STICKY SCAFFOLD
Without Ortho Treatment With Ortho Treatment
ORTHO
TREATMENT
(GREEN)
RECRUITED
CELLS
(BLUE)
2 mm 2 mm
Cells gone after 7 days: Cells present after 7 days:
no cell residency or recruitment promotes residency and cell
recruitment
“Sticky scaffold” Activity
• Stabilizes the blood clot in the injury
• Impedes clot shrinkage
• Sticks to the lesion surfaces
7
ORTHO TREATMENT
A BIOACTIVE SCAFFOLD
BLOOD
VESSELS
(PINK)
5 mm 50 µm
Ortho subcutaneous treatment
at 14 days
“BioActivity”
• Increases vascularization of tissues
• Promotes tissue repair and regeneration
8
PROOF OF CONCEPT
ROTATOR CUFF MODEL
ORTHO INJECTED AT REPAIRED SITE
AFTER TENDON REATTACHMENT
Ortho placed over
and under the SUTURE ANCHORS
tendon after repair
9
ROTATOR CUFF MODEL
TISSUE HEALING
THE TENDON AT 3 MONTHS POST-SURGERY
Standard of Care
Normal Tendon (not injured) (repaired with anchors only) Ortho + Anchors
ORGANIZED IN DISORGANIZED ORGANIZED IN
BUNDLES BUNDLES
250
250µmOrganized in bundles
µm 250 µmDisorganized tissue Organized in bundles
250 µm
Tendon mostly disorganized and Tendon mostly organized in
high levels of GAG* are not bundles with smaller areas of
expressed tendon-like repair tissue
10 *Glycosaminoglycans are implicated in cellular proliferation and wound repairHISTOLOGY SUPPORTS
ROTATOR CUFF HEALING
Normal Tendon Standard of Care Ortho + Anchors
SCAR TISSUE ENDOCHONDRAL
FORMATION OSSIFICATION
GAG
GAG
2.5mm 2.5mm 2.5mm
GAG
GAG
1mm 1mm 1mm
The tendon attachment site at 3 months post-surgery Expression of GAG was abundant at
insertion site, suggesting bone
remodeling through endochondral
ossification is still ongoing
11TISSUE HEALING
MENISCUS TEAR MODEL
Standard of Ortho
Care
Standard of care shows Tear no longer
no healing at 3 months apparent
WITH ORTHO, THE TEAR CAN NO LONGER BE SEEN
123 MONTH DATA
Treatment with 2 mL Ortho-R decreases tendon gap
Normal Control 2 mL Ortho-R
133 MONTH DATA
Treatment with 2 mL Ortho-R improves tendon structural
organization and structural appearance of the enthesis
Normal Control 2 mL Ortho-R
5 mm 5 mm 5 mm
1 mm 1 mm 1 mm
14CLINICAL PLANNING
ROTATOR CUFF
Pilot clinical trial
• 5+ clinical sites; 20-25 patients in each arm
• Primary outcome will be safety (unexpected adverse
events)
Registration clinical trial
• 15-25 sites in the U.S. and Canada, ~200 patients
• 6 month enrollment
• Primary outcomes will be pain and function at 6 months
post operation
• Health economic outcomes for payers will be included
15REGULATORY PROGRESS
Plan is to seek regulatory approval initially in the
U.S. (world’s largest market)
U.S. regulatory agent
• M Squared Associates, Washington, DC and
New York, NY
• Experience with biopolymers and similar
products
Completed a pre-IND meeting with the U.S. FDA
• Ortho will be regulated as a biologic
• Obtained FDA feedback on development plan
16PRODUCT PIPELINE
OVERVIEW
Indication Current Status
Rotator Cuff
POC RESIDENCY DOSE PILOT GMP FINAL IND SAFETY &
ESCALATION MANUFACTURING PIVOTAL REGISTRATION
Meniscus
POC RESIDENCY GMP PILOT FINAL IND SAFETY &
MANUFACTURING PIVOTAL REGISTRATION
Cartilage
POC GMP PILOT RESIDENCY FINAL IND SAFETY &
MANUFACTURING PIVOTAL REGISTRATION
Bone
Healing
(Potential use)
POC GMP PILOT RESIDENCY FINAL IND SAFETY &
MANUFACTURING PIVOTAL REGISTRATION
17BUILDING A SOLID FOUNDATION
FOR FUTURE GROWTH
• Hired key personnel & moved accountants to EY
• Brought on 2 top ‘blue chip’ directors and one renowned
Orthopaedic surgeon to our SAB
• Confirmed patent attorneys and drove IP portfolio to
additional key patents being allowed
• Developed data or “proof” that product is staying where it
is intended to work… “residence”
• Confirmed “dose-response” which may shorten the
timeline for healing to 3 months
• Built multiple BD relationships to create new opportunities
and provided corporate 3rd party validation
• Demonstrated healing induction with MRI and
Histopathology at 3 months
• Scientific evidence accelerating: 15 publications in 2 years
18RECENT & UPCOMING MILESTONES
MULTIPLE VALUE INFLECTION POINTS*
Q3 2018 Q3/4 2019 Q4 2020
Q3/4 2017 Initiate Pivotal IND Submission/ Results and
Critical Ovine sub-studies Study IND Approval submissions
and Efficacy study Preparation
Q4 2018
BusDev Q1 2020
transaction Data Read Out
2017 2018 2019 2020
Q4 2017 Q2/3 2019 Q3 2020
Multiple papers Study completed Last Patient
published, New BOD IND Preparation Out
& SAB members
October 2017 Q4 2018 Q1 2019 Q1 2020 Q4 2020
Trading shares on Targeted Scientific First Patient In Registration
Canadian Stock completion of publications trail approval
Exchange commenced financing
under symbol ORTH
19 * Subject to change pending data and FDAOPPORTUNITY
WELL PROTECTED
Issued United States patent (August 2016)
• U.S. 9,427,469. “Soluble physiological formulations combined with platelet rich
plasma (PRP) for tissue repair”
Notice of Allowance – European PCT (March & May 2018)
• PCT ‘780; Composition of matter: polymer and blood component
• Soluble physiological formulations combined with platelet rich plasma (PRP) for tissue repair
Patent applications
• PCT ‘129; Composition of matter: freeze dried and lyoprotectant for use with PRP, blood and
combinations
• PCT ‘130; Composition and use: Lyophilized scaffold comprising at least one polysaccharide, to
have a variety of beneficial effects e.g. tissue regeneration, angiogenesis, etc.
Legal opinion affirming freedom to operate
20STRONG PARTNERS
AND STRATEGIC INTEREST 2018
• K2M acquired by Stryker for $1.4B
• Cartiva acquired by Wright Medical for $435M
• Emerging Implant Technologies acquired by DePuy Synthes
2017
• Novadaq acquired by Stryker for $900M
• Rotation Medical acquired by Smith & Nephew for $210M
2016
• Cayenne Medical acquired by Zimmer Biomet
• BST Cargel acquired by Smith and Nephew
• Ellipse Technologies acquired by NuVasive for $410 million
2015
• X-Spine acquired by Bacterin for $107 million
• TEI Biosciences acquired by Integra Life Sciences for $312 million
• Spinal Modulation acquired by St. Jude for $215 million
2014
• Symmetry Surgical acquired by Tecomet for $450 million
• Small Bone Innovations (SBI) acquired by Stryker for $375 million
• ArthoCare acquired by Smith and Nephew for $1.7 billion
21MANAGEMENT
RELEVANT EXPERIENCE
Dr. Norton is a leader in the life science industry with operational and directorial experience across
several successful enterprises which achieved significant multiples for investors. Dr. Norton
founded PreMD, completing IPO's and listings on both TSX and AMEX. Operationally, he has built
Brent Norton, MD, MBA, ICD.D
R&D and commercial operations, led transactions with many companies such as AstraZeneca,
Chief Executive Officer Atherogenics, Eli Lilly, L'Oreal, and Parke Davis/Pfizer, and has taken products through the FDA to
global out-licensing with Johnson & Johnson. He is a founding Director of Novadaq Technologies,
one of Canada's most valuable medical companies.
Mr. Mainville has an accomplished history of financial and operational leadership successes within
Luc Mainville, MBA the life science industry. In an executive management career that spans more than 20 years, he
Senior Vice President & Chief Financial has led or been integrally involved in four go-public transactions, completed more than 20 public
Officer financings, and managed more than 50 licensing, merger and acquisition, and sale transactions.
Dr. Mainville also serves as Senior Vice President and CFO for Valeo Pharma.
Dr. Lacasse has an accomplished history of success in the life sciences industry and brings more
than 20 years of drug development experience to Ortho RTi. Prior to joining the company, he held
François-Xavier Lacasse, PhD
senior consulting and executive leadership positions with a number of companies, including
Vice President of Product Development Anapharm Inc., Xanthus Life Sciences Inc., Supratek Pharma Inc., Merck Frosst and LAB
Pharmaceutical Research.
Mr. Skinner has more than fifteen years of experience with healthcare organizations, most notably
Jeff Skinner in the area of business development. He brings a long deal sheet to the Ortho RTi management
Vice President Business Development team, having completed a wide range of deal types in Specialty Pharma, Biotech and Generic
licensing agreements throughout his career.
22LEADERSHIP
PROVEN CORPORATE & SCIENTIFIC
BOARD OF DIRECTORS
• Discovered and developed BST CarGel marketed by Smith & Nephew
Michael Buschmann, PhD
• Professor, Biomaterials and Cartilage Laboratory, George Mason University
Director
• PhD, Massachusetts Institute of Technology and Harvard University
• Professor at EP, MSc, Applied Biology and PhD, Toxicology from MIT
Caroline Hoeman, PhD
• National career fellowships from the Fonds de la Recherche Santé du Quebec (FRQ-S) for
Director
research in biomaterial devices for articular cartilage repair
• Head, Insurance Investment Strategy for OMERS
Sharon Ludlow, CPA, CA, ICD.D
• Accomplished history of executive management success in the insurance industry
Director
• Extensive managerial and governance experience with private and publicly traded companies
Brent Norton, MD, MBA, ICD.D
• Medical Doctor with clinical experience in sports medicine
Executive Chairman of the Board
Steve Saviuk, CA • CA, background in finance and venture capital investing
Director • Co-founded Valeo Pharma in 2003 & served as its President and CEO since its inception
• Accomplished history in global sports and entertainment industry
Tom Wright
• 11th commissioner of the Canadian Football League (CFL)
Director
• Ultimate Fighting Championship (UFC) Exec VP and GM (Canada, Australia & New Zealand)
23LEADERSHIP
PROVEN CORPORATE & SCIENTIFIC
CLINICAL ADVISORY BOARD
• Expert in cartilage and knee restoration and sports medicine
• Subspecialty practice in knee and cartilage restoration; voluntary clinical professor in orthopaedic
Jack Farr, MD
surgery, Indiana University Medical Center
• Indiana Orthopaedic Hospital, St Vincent’s Hospital; MD, Indiana
• Professor, Orthopaedic Surgery, Cornell University
• Attending Surgeon, New York Presbyterian, and The Hospital for Special Surgery
• Head Team Physician, New York Giants football team
Scott Rodeo, MD
• Team Physician, US Olympic Team (2004-2012)
• Co-Chief Emeritus, Sports Medicine and Shoulder Service
• Co-Director, Tissue Engineering, Regeneration, and Repair Program
• Orthopaedic Surgeon, The Royal Orthopaedic Hospital, UK
• Authored 30 publications, 4 book chapters on knee and shoulder injuries
Martyn Snow, MD, MSc
• Presented over 50 papers at various national and international meetings
• Honorary Professor, Birmingham and Aston University
• Practising Orthopaedic Surgeon and Director of Montreal Institute for Special Surgery
• Chief Physician, National Training Center of Tennis Canada, and the Tennis Roger’s Cup
Jacques Toueg, MD
• Physician treating team members of professional sports organizations including NHL, the Major
Junior Hockey League of Quebec, CFL, Boxing Canada
24OWNERSHIP*
HOLDER SHARES OWNERSHIP IN (%)
TOP HOLDERS
Steve Saviuk/Manitex Capital Inc. 4.8 19.8%
Insiders 4.2 17.3%
Polyvalor (École Polytechnique) 1,0 4.1%
TOTAL TOP HOLDERS 10.0 41.2%
Other Holders 14.3 58.8%
BASIC SHARES OUTSTANDING 24.3 100.00%
Options 1.6
Warrants 4.2
FD SHARES OUTSTANDING 30.1
Shares in Escrow 8.6
Shares in Hold period 3.6
FLOAT 12.1 49.8%
25 * As at May 31, 2018INVESTMENT
SUMMARY
• Significant, unmet medical needs in a global
US$5 billion market, growing 8%+ / year
• Earlier product validated mode of action,
clinical efficacy, and safety at 5 years
• First product to market timeline is short, with
clear, manageable end-points
• Active financing and M&A space in tissue
repair, with multiple transactions / exits
• Product sales and royalty revenue potential
from multiple product pipeline
• Opportunity protected by broad global patent
estate
• Proven leadership team
• Demonstrated healing induction with MRI and
Histopathology at 3 months
26
• Scientific evidence accelerating rapidlyCONTACT
Brent Norton MD, MBA, ICD.D
Executive Chairman and CEO
514-782-0951
norton@orthorti.com
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